Effect of intra-articular drain on pain in postoperative arthroscopic anterior cruciate ligament reconstruction: a randomized control trial

Phase 2

• Conditions: Pain after arthroscopic assisted anterior cruciate with semitendinosus graft.; AACRL, Pain, Drain, no Drain, VAS, morphine consumption.

• Registration Number: TCTR20220228001
• Lead Sponsor: Research Affairs, Faculty of Medicine, KK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-28
• Study Completion: 2023-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Volunteer who planned for primary arthroscopic assisted ACL reconstruction with Hamstring
autograft with or without meniscus injury in ipsilateral knee
2. Volunteer's age between 18- 60 year
3. Volunteer who receive spinal anesthesia

Exclusion Criteria

1. Volunteer who has contraindication for spinal anesthesia
2. Volunteer who has renal insufficiency GFR < 30 mL/min
3. Volunteer who has history of cardiovascular thrombotic event, thrombotic stroke and myocardial infarction
4. Volunteer who has history of peptic ulcer or GI bleeding
5. Volunteer who has previously undergone arthroscopic assisted ACL reconstruction
6. Volunteer who has ACL injury with bone fracture
7. Volunteer who is allergic to Ketorolac, Morphine, Transamine, Parecoxib, paracetamol
8. Volunteer who has drug or alcohol addiction or has chronic pain
9. Volunteer who receive steroid within 48 hours prior to surgery
10. Volunteer who has mental problems or unable to communicate
11. Volunteer who refuse to join the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain pre-op, 6,12,24,36,48 hours post operation (but VAS at 48 hours post operation is the primary outcome) Visual analogue scale

Secondary Outcome Measures

Name	Time	Method
Pain 6, 12, 24, 36 hours post operation Visual analogue scale ,morphine consumption 6,12,24,36,48 hours post operation morphine consumption from IV PCA,Straight leg raising test before surgery and 48 hours post operation Raise the leg 30 degrees from the horizontal line and maintain for 3 seconds,Incidence of knee joint aspiration within 48 hours post operation Count the knee joint aspiration event,Hemarthrosis grading before surgery and 48 hours post operation 7.Clinical grading of hemarthrosis by Coupens and Yates